The following data is part of a premarket notification filed by Innobiosurg Co., Ltd with the FDA for Ibs Implant System.
| Device ID | K153350 |
| 510k Number | K153350 |
| Device Name: | IBS Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INNOBIOSURG CO., LTD 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 305-510 |
| Contact | Bo-reum Yoo |
| Correspondent | April Lee WITHUS GROUP INC 2531 PEPPERDALE DRIVE Rowland Heights, CA 91748 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039380591 | K153350 | 000 |
| 08800039379762 | K153350 | 000 |
| 08800039379779 | K153350 | 000 |
| 08800039379786 | K153350 | 000 |
| 08800039379793 | K153350 | 000 |
| 08800039379809 | K153350 | 000 |
| 08800039379816 | K153350 | 000 |
| 08800039379823 | K153350 | 000 |
| 08800039379830 | K153350 | 000 |
| 08800039379847 | K153350 | 000 |
| 08800039380607 | K153350 | 000 |
| 08800039379755 | K153350 | 000 |